Bureaucracy still weighs heavily in European site selection

Bureaucratic barriers and administrative burdens remain significant impediments to running clinical trials in Europe, a new survey has found.

The results of the research by the SAT-EU study group, an independent non-profit collaborative initiative supported by the European Forum for Good Clinical Practice and a number of trade and not-for profit organisations, comes as the European Union’s overhaul of the clinical trial Directive (2001/20/EC) nears its final legislative hurdle.

Much of the impulse for the proposed regulation on clinical trials, which European legislators hope to finalise before Christmas, came from complaints about bureaucracy, slow processes and disparities in national regulations dulling the competitiveness of Europe as a go-to location for clinical trials while emerging markets picked up the slack.

Applications to run clinical trials in Europe fell by 25% between 2007 and 2011, noted the authors of ‘Factors Influencing Clinical Trial Site Selection in Europe: The Survey of Attitudes towards Trial sites in Europe’ (The SAT-EU StudyTM), which was published online through the British Medical Journal’s BMJ Open channel.

It found that administrative burdens and unhelpful bureaucratic hurdles were key deterrents to running clinical trials in Europe.

By contrast, trial costs, and in particular government financial/tax incentives, were regarded as significantly less important in determining site selection.

Becoming more competitive

Digging deeper, the researchers explored ways in which European clinical research might become more competitive.

Facilitating access to pan-European disease-area experts and to centres of excellence through more disease-management networks would help to steer clinical trials towards optimal patient recruitment, the survey found.

Participants also viewed making clinical-trial units more visible through dedicated websites as a highly desirable attribute in driving competitiveness.

Best-practice audit

There was considerable variability in countries’ perceived receptiveness towards clinical trials, although Germany, the United Kingdom and the Netherlands consistently rated as the most attractive markets for studies.

The authors suggested a best-practice audit of clinical-trial provisions in these countries might be useful.

“The case for action rests on the realisation that evidence-based policy is indeed possible in this arena,” they stated.

“Learning from what is working successfully will facilitate the road to creating a more welcoming environment for clinical research in Europe.”

Speed is critical

For Giuseppe Ambrosio, Professor of Cardiology at the University of Perugia in Italy and co-author of the study, speed to trial start-up “is critical”.

What survey participants wanted, Ambrosio said, was less national variability in clinical-trial applications; streamlined approvals by competent authorities and ethics committees; and less complex hospital contracting (e.g., via national or pan-European templates).

“Our work suggests that a stronger pan-European element in the trial-application process will greatly benefit European clinical research by bringing more studies to Europe, encouraging additional investments, and fostering collaboration at a high level among hospitals Europe-wide,” he added.